Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

Brief Title

Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

Official Title

A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors

Brief Summary

      This phase II trial is studying how well sorafenib tosylate works in treating patients with
      progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor
      cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to
      the tumor.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the objective tumor response rate of BAY 43-9006 (sorafenib tosylate) in
      patients with advanced neuroendocrine tumors.

      SECONDARY OBJECTIVES:

      I. Adverse event rate(s). II. Progression free survival and time to progression. III.
      Improvement in circulating hormone levels. IV. Overall survival.

      OUTLINE: This is a multicenter study. Patients are grouped into 2 separate analysis Groups
      according to tumor type (Group A: Carcinoid; Group B: Islet cell/other well-differentiated
      tumor). Each Group was independently evaluated for all study endpoints.

      Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28
      days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months until disease
      progression and then every 6 months for up to 2 years from study entry.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Confirmed Response Rate

Secondary Outcome

 Toxicity

Condition

Gastrinoma

Intervention

sorafenib tosylate

Study Arms / Comparison Groups

 Group A (patients with carcinoid tumors)
Description:  Patients receive 400 mg oral sorafenib twice daily on days 1-28.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

93

Start Date

June 2005

Completion Date

April 2013

Primary Completion Date

October 2010

Eligibility Criteria

        Criteria:

          -  Histologically confirmed neuroendocrine tumor:

               -  Carcinoid tumor OR islet cell carcinoma/other well-differentiated tumor

               -  No anaplastic or high-grade histology

               -  Metastatic disease

          -  Measurable disease

          -  No thyroid carcinoma of any histology, thymoma, or pheochromocytoma/paraganglioma

          -  No known brain metastases

          -  Performance status:

               -  Eastern Cooperative Oncology Group (ECOG) 0-2

          -  Life expectancy:

               -  At least 24 weeks

          -  Hematopoietic:

               -  Absolute neutrophil count >= 1,500/mm3

               -  Platelet count >= 100,000/mm3

               -  No bleeding diathesis

          -  Hepatic:

               -  Bilirubin =< 2 times upper limit of normal (ULN)

               -  Aspartate aminotransferase (AST) =< 3 times ULN (5 times ULN if liver metastases
                  are present)

               -  International normalized ratio (INR) normal

               -  PTT normal

          -  Renal:

               -  Creatinine =< 1.5 times ULN

          -  Cardiovascular:

        No poorly controlled hypertension; No symptoms of congestive heart failure; No unstable
        angina pectoris; No cardiac arrhythmia

          -  Gastrointestinal:

               -  Able to swallow capsules intact

               -  No gastrointestinal tract disease resulting in an inability to take oral
                  medication (e.g., dysphagia)

               -  No requirement for IV alimentation

               -  No active peptic ulcer disease

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other invasive malignancy within the past 3 years except adequately treated basal
             cell or squamous cell skin cancer or carcinoma in situ of the cervix

          -  No other uncontrolled illness

          -  At least 4 weeks since prior interferon

          -  No more than 1 prior systemic chemotherapy regimen:

        Chemoembolization is not considered systemic chemotherapy

          -  At least 4 weeks since prior chemoembolization

          -  At least 3 weeks since prior radiotherapy

          -  No prior procedures adversely affecting intestinal absorption

          -  At least 4 weeks since prior hepatic artery embolization

          -  No other prior systemic therapy

          -  No other concurrent investigational treatment

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, or
             phenytoin)

          -  No concurrent rifampin

          -  No concurrent Hypericum perforatum (St. John's wort)

          -  Prior or concurrent octreotide for symptomatic treatment allowed

          -  No concurrent therapeutic anticoagulation:

        Concurrent prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial
        access devices allowed provided requirements for INR or PTT are met

          -  At least 4 weeks since prior major surgery

          -  Recovered from all prior therapy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Timothy Hobday, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00131911

Organization ID

NCI-2009-00121

Secondary IDs

MC044H

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Timothy Hobday, Principal Investigator, Mayo Clinic


Verification Date

June 2014